NCT05293106终止4 期
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
研究概览
简要总结
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
详细描述
This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 0 up to and including 18 years of age
- •Undergoing elective cardiopulmonary bypass surgery
- •Are planned to have a chest tube placed in the operating room prior to chest closure
排除标准
- •>/=19 years of age
- •Preterm infants (less than 38-week gestational age at time of surgery)
- •On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- •Family requests limitation of blood products (i.e. Jehovah's Witness)
- •Congenital bleeding disorder
- •Are planned to require ECMO post-op
- •Previously enrolled in the study
结局指标
主要结局
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
时间窗: Within the first 24 hours post-op.
Chest tube output for first 24 hours following cardiopulmonary bypass surgery
次要结局
- Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
- Total Platelet Volume Transfused in the First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
- Total Plasma Volume Transfused in the First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
- Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.(During hospitalization in the first 48 hours (no follow-up visits necessary))
研究者
研究点 (2)
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